Senior manager, Risk management strategy

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Functional Area Description The WWPS-J group is responsible for ensuring the safety of our medicines by conducting the following: ・pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, ・safety reporting, contribution to benefit-risk assessment, ・risk management planning and strategy, and ・execution of post-marketing commitments ・ensuring compliance with global regulatory requirements. Position Summary This role provides leadership as a senior level safety scientist ・To lead Strategic Safety Management in BMSKK ・To develop RMS organization to provide maximum outcome effectively with embody our mission, vision and value ・To lead the optimal operations with strategic planning in order to realize risk minimalization by planning, operating, and promoting of activities ・To ensure benefit-risk balance across the product lifecycle for the products by executing appropriate safety measures. ・To ensure the safety of the subject in clinical studies. ・To contribute NDA activities from the safety perspective for the patients’ early and appropriate access to the products. ・To ensure excellent regulatory compliance and credibility. Position Responsibilities 1.Risk management 　Conducts safety review and potential signal detection and proposes the safety measures and safety communications for the products 　Prepares and submits the initial and updated J-RMPs 　Drafts and updates the precautions in J-PI 　Reviews or prepares the safety part of the documents of clinical studies (Protocol, ICF, IB, CSR, etc.) 　Prepares the response to the inquiries from PMDA for NDA and post-marketing phase 　Prepares and provides the materials for proper use (Proper use guide, Patient leaflet, Interim/ Final report of EPPV, etc.) 　Plans and implements EPPV. 　Plans and implements safety assurance measures 2.Safety reports 　Prepares and submits periodic reports (J-DSUR and Non-serious unexpected adverse reactions report) to PMDA. Drafts the part of safety part of J-PSUR. 　Prepares and submits EPPV reports to PMDA. 　Prepares and submits research reports and safety measure reports to PMDA. 　Prepares the applications for re-examination and re-evaluation 3. Cross-functional collaboration 　Supports the clinical study team from safety perspective 　Collaborates with relevant departments to ensure safety measures 　Trains staff on product safety profile and risk minimization measures. 　Contributes to ensure the benefit-risk profiles. 4. Safety control activities/ compliance 　Ensures the awareness of the changes in regulations and evaluates the impact on local processes. 　Ensures the appropriate safety vigilance procedure and in interactions with other department and Global Drug Safety and Risk Management (GDSRM). 5. Development of organizational culture 　Supports of culture cultivation such as our mission, vision and value 　Leads team members for ensuring the implementation of company policies, SOPs, processes, etc 6. Organizational management 　Coachs and mentors to develop RMS members 　Manages budget and outsources tasks to slim down Degree Requirements 1.Minimum of B.S. or the equivalent education in life science 2.Fluent in Japanese and English with ability to work in global context Experience Requirements Required experience 1.Ten (10) years pharmaceutical/biotechnology industry experience 2.Ten (10) years drug safety experience 3.Clinical experience preferred 4.Management experience preferred Required knowledge ・Pharmaceutical and Science background ・Mastery of global / local Pharmacovigilance/safety regulatory requirement (Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations, GCP, GVP, GPSP, etc.) ・Proficiency in safety processing (GVP-SOP, Global SOP, etc.) Key Competency Requirements 1.Scientific/Technical thinking 2.Group Leadership 3.Communication/ cross-functional collaboration skill 4.Presentation skills Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.